StrokeNCT05306522
The Effects of Telerehabilitation-Based Spinal Stabilization Exercises in Stroke Patients
A study testing Spinal stabilization exercise in people with Stroke, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
Stroke is a disease that causes sudden focal neurologic function loss lasting longer than 24 hours due to infarction or hemorrhage in relevant part of the central nervous system. Stroke causes a variety of physiological and psychological symptoms. Read more about this study
- Who is it for?
- Ages 50 to 75 years
- Conditions the study is for
- Stroke
- What is being tested?
- Spinal stabilization exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 4 Apr 2022to Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged between 50-75 years
- Having an ischemic stroke with anterior circulation involvement
- Getting a score of 24 or higher on the Mini Mental Test
- Ambulation in indoor and outdoor environments with or without a walking aid (walker, cane or tripod)
- At least 1 year has passed since the stroke event
- To have the necessary infrastructure (internet) and equipment (smartphone, tablet or computer) for the telerehabilitation application
- Not participating in any physiotherapy program in the last 6 months
- Volunteering to participate in the study
Who cannot join
- Having a history of more than one stroke
- Having a known orthopedic, psychiatric or other neurological disease
- Having a history of surgery involving the lower extremities, abdominal region or gait
- Known presence of dementia
- Presence of aphasia and apraxia
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Hacettepe University, Faculty of Physical Therapy and Rehabilitation
Ankara
Kadriye Armutlu, Professor, +903123051572, karmulu@hacettepe.edu.tr
Ayla Fil Balkan, Associate Professor, +903123051576, aylafil@gmail.com
About this study
Official title: The Effects of Telerehabilitation-Based Spinal Stabilization Exercises on Physical Activity Level and Fatigue in Chronic Stroke Patients
Stroke is a disease that causes sudden focal neurologic function loss lasting longer than 24 hours due to infarction or hemorrhage in relevant part of the central nervous system. Stroke causes a variety of physiological and psychological symptoms. These symptoms can negatively affect physical activity level and fatigue. Spinal stabilization exercises based on the basic principles of motor learning improves the coordination and endurance of the body muscles by increasing kinesthetic awareness, so this exercise approach can be used to strengthen body stability. The aim of this study is to investigate the effects of telerehabilitation based spinal stabilization exercises on physical activity level and fatigue in community dwelling stroke patients.
Read the detailed description
Stroke is defined as a neurological disorder that causes acute focal damage to the Central Nervous System due to a vascular cause. Ischemic stroke and hemorrhagic stroke are the two most fundamental types of stroke. Approximately 80% of patients suffer from ischemic stroke, whereas 20% suffer from hemorrhagic stroke. Ischemic strokes usually develop due to arterial occlusions, rarely cerebral veins or venous sinus occlusions. Hemorrhagic strokes develop as intracerebral or subarachnoid hemorrhages.
It happens as a result of a ruptured aneurysm or a ruptured cerebral artery. The clinical presentation after stroke differs according to the affected artery, underlying etiology, localization and size of the affected area. Motor, sensory and cognitive problems such as paresis, spasticity, gait and balance disorders, sensory and visual problems, fatigue, aphasia, depression, apraxia, agnosia, and amnesia may occur after stroke. These symptoms reduce the quality of life of patients and negatively affect daily living activities. In addition, as a result of all these problems, the physical activity levels of the patients decrease. These post-stroke symptoms reveal the need for rehabilitation in these patients. In the literature, there are many rehabilitation approaches after stroke. The main purpose of these approaches is to improve the functional level of patients and to ensure their independence in activities of daily living at the highest possible level.
Spinal stabilization exercises improve trunk stabilization by increasing the activation of the core muscles that wrap the trunk like a corset. The aim of spinal stabilization exercises is to strengthen core muscles, support the vertebral column, provide optimal posture by increasing kinesthetic awareness, and facilitate movements with breathing. In the literature, it has been shown that spinal stabilization exercises improve balance and gait, reduce fatigue, increase the trunk control of the patients, increase the strength of the core muscles, decrease the fear of falling, improve respiratory functions and have positive effects on activities of daily living in stroke patients.
Telerehabilitation has been one of the important research areas of stroke rehabilitation in recent years. It not only provides a treatment opportunity for patients with limited access to rehabilitation centers, but also provides an opportunity to follow-up the rehabilitation of the patients treated in the rehabilitation center after discharge. Physiotherapists reach patients with telecommunication devices (smartphone, tablet, computer) and provide online rehabilitation services.
In this study, it is aimed to increase trunk stabilization with spinal stabilization exercises. The development of trunk stabilization will reduce the load on both the trunk and the extremities, thus reducing the energy expenditure of the patients while performing their daily living activities. As a result, it is predicted that there may be an increase in the functional activity levels of the patients and a decrease in their fatigue. In the literature, there is no study in which spinal stabilization exercises were applied on the basis of telerehabilitation in stroke patients. In addition, there is no study in the literature investigating the effect of spinal stabilization exercises on the physical activity level of stroke patients. This trial is original in these respects. In this study, the effects of telerehabilitation-based spinal stabilization exercises on physical activity level and fatigue in stroke patients will be investigated.
Method: This study was planned as a mixed-type research design in which quantitative and qualitative research methods were used together to investigate the effects of telerehabilitation-based spinal stabilization exercises on physical activity level and fatigue in chronic stroke patients. In the quantitative evaluations of the study, primarily physical activity level and fatigue; secondarily, functional capacity, trunk involvement and quality of life will be evaluated. In the qualitative phase of the study, interviews will be conducted about the patients' experiences with physical activity and fatigue before and after the exercise program. In addition, after the exercise program, the patients will be interviewed about their experiences with the exercises.
The sample size of the study was calculated using the G*Power 3.1 software, considering the study of Yoon et al. It was determined that a total of 24 patients, 12 for each exercise group, should be taken. However, considering the possible data losses, it is planned to include a total of 30 patients, 15 patients in each group, into the study.
Patients will be placed into groups by block randomization method. Also, this study is planned as a single-blind study. The patients in the study group will be given telerehabilitation-based spinal stabilization exercises. The patients in the control group will be given face-to-face spinal stabilization exercises.
Kadriye Armutlu will make the randomization. Evaluation of the patients will be done by Ayla Fil Balkan (AFB). The treatment programs of the patients will be implemented by Ali Naim Ceren (ANC). AFB will make the evaluations without knowing which group the patients are in. Thus, it will be ensured that the study is single-blind. Also, to avoid bias, the ANC will not be informed of the patients' evaluation results until the study is finished.
A qualitative interview will be conducted first with all patients who meet the inclusion criteria. After the qualitative interview, all patients will be fitted with a smart wristband to determine their physical activity level, and they will be asked to stay on the wristband for 7 days, including while they sleep (except when they take a bath). At the end of these 7 days, the wristband will be taken from the patients and the remaining evaluations will be made. After the evaluations are over, the patients will be directed to the physiotherapist who will implement the exercise program. Before starting the treatment programs, the physiotherapist will explain the activation methods of the transversus abdominus and multifidus muscles to the patients face-to-face for a total of 3 days, every other day. In this direction, the activation of the transversus abdominus muscle, which the patients can easily feel and palpate with their hands, will be taught. At the end of this period, if there are patients who cannot contract the transversus abdominus muscle correctly, these patients will be dropped out of the study. Afterwards, spinal stabilization exercise programs will be started online with the patients in the telerehabilitation group and face-to-face with the patients in the control group. In both groups, the exercise programs will last for 1 hour, 3 days a week, for a total of 6 weeks. Fatigue, functional capacity, trunk control, trunk endurance and quality of life evaluations will be performed on all patients 1 day after the exercise program is completed, and smart wristbands will be placed on the patients after the evaluation. Likewise, it will be required to keep the wristband on for 7 days (except for the time they take a bath), including while sleeping. At the end of these 7 days, the smart wristbands will be taken from the patients and a qualitative interview will be conducted.
- Conditions
- Stroke
- Being tested
- Spinal stabilization exercise
- Keywords
- stroke, spinal stabilization exercise, telerehabilitation, fatigue, physical activity
- Medical subject headings
- Stroke, Fatigue, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spinal stabilization exerciseOther
The effects of telerehabilitation based spinal stabilization exercise in chronic stroke patients will be investigated.
| Study group | Role | What they receive |
|---|---|---|
| Telerehabitation Group | Experimental | Patients will undergo telerehabilitation based spinal stabilization exercise 3 days per week for 6 weeks. Receives: Other: Spinal stabilization exercise |
| Face to face Group | Experimental | Patients will undergo spinal stabilization exercise 3 days per week for 6 weeks. Receives: Other: Spinal stabilization exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of Physical Activity Level (the mean of the number of steps)
It is planned to measure the physical activity levels of the patients with the Xiaomi Mi Smart Wristband 4.0. It measures the number of steps taken by the users
The following information will be saved:
The number of steps in one day: .........steps (the mean of steps in seven days)
Measured: 6 weeks
Assessment of Physical Activity Level (the distance of the patient walks)
It is planned to measure the physical activity levels of the patients with the Xiaomi Mi Smart Wristband 4.0. It measures the distance the patient walk.
The following information will be saved:
The distance the patients walks in one day:........meters (the mean of the distance in seven days)
Measured: 6 weeks
Assessment of Physical Activity Level (the time the patient sleeps)
It is planned to measure the physical activity levels of the patients with the Xiaomi Mi Smart Wristband 4.0. It measures the time the patient sleeps.
The following information will be saved:
The time the patient sleeps in one day:......minutes (the mean of sleep time in seven days)
Measured: 6 weeks
Assessment of Physical Activity Level (the calories the patient burns)
It is planned to measure the physical activity levels of the patients with the Xiaomi Mi Smart Wristband 4.0. It measures the calories the patients burn.
The following information will be saved:
he burned calories in one day:..........calories (the mean of the burned calories in seven days)
Measured: 6 weeks
Fatigue Assessment (physical fatigue)
Fatigue will be assessed with Fatigue Severity Scale (FSS). FSS is a scale with scores ranging from 7 to 63. It includes 9 items. Increase of the score shows severe fatigue.
Measured: 6 weeks
Fatigue Assessment (cognitive, physical and psychosocial fatigue)
Fatigue will be assessed with Fatigue İmpact Scale (FIS). FIS is a scale with scores ranging from 0 to 160. . It includes 40 items. It has 3 subscales; cognitive fatigue (10 items), physical fatigue (10 items) and psychosocial fatigue (20 items).
Measured: 6 weeks
Fatigue Assessment (ambulatory fatigue)
Fatigue will be assessed with linear trend of fatigue. Linear trend of fatigue is calculated from the 6 Minute Walk Test. The formula: ([(-5*D1)+(-3*D2)+(-1*D5)+(1*D4)+(3*D5)+(5*D6)])/70 (D1=1 Distance walked in 1st minute, D2=Distance walked in 2nd minute, D3=Distance walked in 3rd minute, D4= Distance walked in 4th minute, D5= Distance walked in 5th minute, D6= distance walked in 6th minute)
Measured: 6 weeks
Secondary outcomes (4)
Functional Capacity Assessment
Functional capacity will be assessed with 6 Minute Walk Test. The distance the patient walks in 6 minutes will be recorded.
Measured: 6 weeks
Trunk İmpairment Assessment
Trunk İmpairment will be assessed with Trunk Impairment Scale. It consists of 17 items, 3 items evaluating static sitting balance, 10 items evaluating dynamic sitting balance, and 4 items evaluating coordination. The score obtained from the scale is between 0-23, and a high score is an indicator of good trunk control.
Measured: 6 weeks
Assessment of the Endurance of Core Muscles
The McGill protocol will be applied to assess the endurance of the core muscles. This protocol consists of a combination of 4 tests; modified Biering-Sorenson test, trunk flexor endurance test, right and left lateral bridge (lateral plank) tests. Modified Biering-Sorenson test; evaluates the endurance of trunk extensors.
Measured: 6 weeks
Quality of Life Assessment
Quality of Life will be assessed with Stroke Impact Scale 3.0. This scale includes 59 items in 8 subsections, and is scored on a 5-point Likert scale. Each section is scored from 0 to 100 in itself. 8 subsections of the scale; assesses strength, hand function, activities of daily living, mobility, communication, emotion, memory and participation. In addition to these 8 sections, there is a visual analog scale of 0-100 points at the end of the scale that evaluates the perception of recovery after stroke
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2022
- Study start4 Apr 2022
- Primary completionJun 2024 (estimated)
- Study completionJun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (33)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Hacettepe UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ali Naim Ceren, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05306522
- Sponsor's protocol ID
- KA-21098
- Status last verified
- Feb 2024
- First submitted
- 19 Feb 2022
- Last updated
- 1 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Grysiewicz RA, Thomas K, Pandey DK. Epidemiology of ischemic and hemorrhagic stroke: incidence, prevalence, mortality, and risk factors. Neurol Clin. 2008 Nov;26(4):871-95, vii. doi: 10.1016/j.ncl.2008.07.003.
PubMed 19026895Shepherd AI, Pulsford R, Poltawski L, Forster A, Taylor RS, Spencer A, Hollands L, James M, Allison R, Norris M, Calitri R, Dean SG. Physical activity, sleep, and fatigue in community dwelling Stroke Survivors. Sci Rep. 2018 May 21;8(1):7900. doi: 10.1038/s41598-018-26279-7.
PubMed 29785009Akuthota V, Ferreiro A, Moore T, Fredericson M. Core stability exercise principles. Curr Sports Med Rep. 2008 Feb;7(1):39-44. doi: 10.1097/01.CSMR.0000308663.13278.69.
PubMed 18296944Sacco RL, Kasner SE, Broderick JP, Caplan LR, Connors JJ, Culebras A, Elkind MS, George MG, Hamdan AD, Higashida RT, Hoh BL, Janis LS, Kase CS, Kleindorfer DO, Lee JM, Moseley ME, Peterson ED, Turan TN, Valderrama AL, Vinters HV; American Heart Association Stroke Council, Council on Cardiovascular Surgery and Anesthesia; Council on Cardiovascular Radiology and Intervention; Council on Cardiovascular and Stroke Nursing; Council on Epidemiology and Prevention; Council on Peripheral Vascular Disease; Council on Nutrition, Physical Activity and Metabolism. An updated definition of stroke for the 21st century: a statement for healthcare professionals from the American Heart Association/American Stroke Association. Stroke. 2013 Jul;44(7):2064-89. doi: 10.1161/STR.0b013e318296aeca. Epub 2013 May 7.
PubMed 23652265Boehme AK, Esenwa C, Elkind MS. Stroke Risk Factors, Genetics, and Prevention. Circ Res. 2017 Feb 3;120(3):472-495. doi: 10.1161/CIRCRESAHA.116.308398.
PubMed 28154098Campbell BCV, Khatri P. Stroke. Lancet. 2020 Jul 11;396(10244):129-142. doi: 10.1016/S0140-6736(20)31179-X.
PubMed 32653056Geyh S, Cieza A, Schouten J, Dickson H, Frommelt P, Omar Z, Kostanjsek N, Ring H, Stucki G. ICF Core Sets for stroke. J Rehabil Med. 2004 Jul;(44 Suppl):135-41. doi: 10.1080/16501960410016776.
PubMed 15370761Chen C, Leys D, Esquenazi A. The interaction between neuropsychological and motor deficits in patients after stroke. Neurology. 2013 Jan 15;80(3 Suppl 2):S27-34. doi: 10.1212/WNL.0b013e3182762569.
PubMed 23319483Paciaroni M, Acciarresi M. Poststroke Fatigue. Stroke. 2019 Jul;50(7):1927-1933. doi: 10.1161/STROKEAHA.119.023552. Epub 2019 Jun 14. No abstract available.
PubMed 31195940Thilarajah S, Mentiplay BF, Bower KJ, Tan D, Pua YH, Williams G, Koh G, Clark RA. Factors Associated With Post-Stroke Physical Activity: A Systematic Review and Meta-Analysis. Arch Phys Med Rehabil. 2018 Sep;99(9):1876-1889. doi: 10.1016/j.apmr.2017.09.117. Epub 2017 Oct 19.
PubMed 29056502Belagaje SR. Stroke Rehabilitation. Continuum (Minneap Minn). 2017 Feb;23(1, Cerebrovascular Disease):238-253. doi: 10.1212/CON.0000000000000423.
PubMed 28157752Key J. 'The core': understanding it, and retraining its dysfunction. J Bodyw Mov Ther. 2013 Oct;17(4):541-59. doi: 10.1016/j.jbmt.2013.03.012. Epub 2013 Jun 28.
PubMed 24139017Lee NG, You JSH, Yi CH, Jeon HS, Choi BS, Lee DR, Park JM, Lee TH, Ryu IT, Yoon HS. Best Core Stabilization for Anticipatory Postural Adjustment and Falls in Hemiparetic Stroke. Arch Phys Med Rehabil. 2018 Nov;99(11):2168-2174. doi: 10.1016/j.apmr.2018.01.027. Epub 2018 Feb 21.
PubMed 29476713Karthikbabu S, Ganesan S, Ellajosyula R, Solomon JM, Kedambadi RC, Mahabala C. Core Stability Exercises Yield Multiple Benefits for Patients With Chronic Stroke: A Randomized Controlled Trial. Am J Phys Med Rehabil. 2022 Apr 1;101(4):314-323. doi: 10.1097/PHM.0000000000001794.
PubMed 34001840Chung E, Lee BH, Hwang S. Core stabilization exercise with real-time feedback for chronic hemiparetic stroke: a pilot randomized controlled trials. Restor Neurol Neurosci. 2014;32(2):313-21. doi: 10.3233/RNN-130353.
PubMed 24398718
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Telerehabilitation-Based Spinal Stabilization Exercises on Physical Activity Level and Fatigue in Chronic Stroke Patients
- ClinicalTrials.gov ID
- NCT05306522
- Acronym / sponsor ID
- KA-21098
- Conditions
- Stroke
- Keywords
- stroke, spinal stabilization exercise, telerehabilitation, fatigue, physical activity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 4 Apr 2022 (actual)
- Primary completion
- Jun 2024 (estimated)
- Study completion
- Jun 2024 (estimated)
- First posted
- 1 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Stroke is a disease that causes sudden focal neurologic function loss lasting longer than 24 hours due to infarction or hemorrhage in relevant part of the central nervous system. Stroke causes a variety of physiological and psychological symptoms. These symptoms can negatively affect physical activity level and fatigue. Spinal stabilization exercises based on the basic principles of motor learning improves the coordination and endurance of the body muscles by increasing kinesthetic awareness, so this exercise approach can be used to strengthen body stability. The aim of this study is to investigate the effects of telerehabilitation based spinal stabilization exercises on physical activity level and fatigue in community dwelling stroke patients.
Detailed description
Stroke is defined as a neurological disorder that causes acute focal damage to the Central Nervous System due to a vascular cause. Ischemic stroke and hemorrhagic stroke are the two most fundamental types of stroke. Approximately 80% of patients suffer from ischemic stroke, whereas 20% suffer from hemorrhagic stroke. Ischemic strokes usually develop due to arterial occlusions, rarely cerebral veins or venous sinus occlusions. Hemorrhagic strokes develop as intracerebral or subarachnoid hemorrhages.
It happens as a result of a ruptured aneurysm or a ruptured cerebral artery. The clinical presentation after stroke differs according to the affected artery, underlying etiology, localization and size of the affected area. Motor, sensory and cognitive problems such as paresis, spasticity, gait and balance disorders, sensory and visual problems, fatigue, aphasia, depression, apraxia, agnosia, and amnesia may occur after stroke. These symptoms reduce the quality of life of patients and negatively affect daily living activities. In addition, as a result of all these problems, the physical activity levels of the patients decrease. These post-stroke symptoms reveal the need for rehabilitation in these patients. In the literature, there are many rehabilitation approaches after stroke. The main purpose of these approaches is to improve the functional level of patients and to ensure their independence in activities of daily living at the highest possible level.
Spinal stabilization exercises improve trunk stabilization by increasing the activation of the core muscles that wrap the trunk like a corset. The aim of spinal stabilization exercises is to strengthen core muscles, support the vertebral column, provide optimal posture by increasing kinesthetic awareness, and facilitate movements with breathing. In the literature, it has been shown that spinal stabilization exercises improve balance and gait, reduce fatigue, increase the trunk control of the patients, increase the strength of the core muscles, decrease the fear of falling, improve respiratory functions and have positive effects on activities of daily living in stroke patients.
Telerehabilitation has been one of the important research areas of stroke rehabilitation in recent years. It not only provides a treatment opportunity for patients with limited access to rehabilitation centers, but also provides an opportunity to follow-up the rehabilitation of the patients treated in the rehabilitation center after discharge. Physiotherapists reach patients with telecommunication devices (smartphone, tablet, computer) and provide online rehabilitation services.
In this study, it is aimed to increase trunk stabilization with spinal stabilization exercises. The development of trunk stabilization will reduce the load on both the trunk and the extremities, thus reducing the energy expenditure of the patients while performing their daily living activities. As a result, it is predicted that there may be an increase in the functional activity levels of the patients and a decrease in their fatigue. In the literature, there is no study in which spinal stabilization exercises were applied on the basis of telerehabilitation in stroke patients. In addition, there is no study in the literature investigating the effect of spinal stabilization exercises on the physical activity level of stroke patients. This trial is original in these respects. In this study, the effects of telerehabilitation-based spinal stabilization exercises on physical activity level and fatigue in stroke patients will be investigated.
Method: This study was planned as a mixed-type research design in which quantitative and qualitative research methods were used together to investigate the effects of telerehabilitation-based spinal stabilization exercises on physical activity level and fatigue in chronic stroke patients. In the quantitative evaluations of the study, primarily physical activity level and fatigue; secondarily, functional capacity, trunk involvement and quality of life will be evaluated. In the qualitative phase of the study, interviews will be conducted about the patients' experiences with physical activity and fatigue before and after the exercise program. In addition, after the exercise program, the patients will be interviewed about their experiences with the exercises.
The sample size of the study was calculated using the G*Power 3.1 software, considering the study of Yoon et al. It was determined that a total of 24 patients, 12 for each exercise group, should be taken. However, considering the possible data losses, it is planned to include a total of 30 patients, 15 patients in each group, into the study.
Patients will be placed into groups by block randomization method. Also, this study is planned as a single-blind study. The patients in the study group will be given telerehabilitation-based spinal stabilization exercises. The patients in the control group will be given face-to-face spinal stabilization exercises.
Kadriye Armutlu will make the randomization. Evaluation of the patients will be done by Ayla Fil Balkan (AFB). The treatment programs of the patients will be implemented by Ali Naim Ceren (ANC). AFB will make the evaluations without knowing which group the patients are in. Thus, it will be ensured that the study is single-blind. Also, to avoid bias, the ANC will not be informed of the patients' evaluation results until the study is finished.
A qualitative interview will be conducted first with all patients who meet the inclusion criteria. After the qualitative interview, all patients will be fitted with a smart wristband to determine their physical activity level, and they will be asked to stay on the wristband for 7 days, including while they sleep (except when they take a bath). At the end of these 7 days, the wristband will be taken from the patients and the remaining evaluations will be made. After the evaluations are over, the patients will be directed to the physiotherapist who will implement the exercise program. Before starting the treatment programs, the physiotherapist will explain the activation methods of the transversus abdominus and multifidus muscles to the patients face-to-face for a total of 3 days, every other day. In this direction, the activation of the transversus abdominus muscle, which the patients can easily feel and palpate with their hands, will be taught. At the end of this period, if there are patients who cannot contract the transversus abdominus muscle correctly, these patients will be dropped out of the study. Afterwards, spinal stabilization exercise programs will be started online with the patients in the telerehabilitation group and face-to-face with the patients in the control group. In both groups, the exercise programs will last for 1 hour, 3 days a week, for a total of 6 weeks. Fatigue, functional capacity, trunk control, trunk endurance and quality of life evaluations will be performed on all patients 1 day after the exercise program is completed, and smart wristbands will be placed on the patients after the evaluation. Likewise, it will be required to keep the wristband on for 7 days (except for the time they take a bath), including while sleeping. At the end of these 7 days, the smart wristbands will be taken from the patients and a qualitative interview will be conducted.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Telerehabitation Group | Experimental | Other: Spinal stabilization exercisePatients will undergo telerehabilitation based spinal stabilization exercise 3 days per week for 6 weeks. |
| Face to face Group | Experimental | Other: Spinal stabilization exercisePatients will undergo spinal stabilization exercise 3 days per week for 6 weeks. |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Aged between 50-75 years
- Having an ischemic stroke with anterior circulation involvement
- Getting a score of 24 or higher on the Mini Mental Test
- Ambulation in indoor and outdoor environments with or without a walking aid (walker, cane or tripod)
- At least 1 year has passed since the stroke event
Key exclusion criteria (5 listed)
- Having a history of more than one stroke
- Having a known orthopedic, psychiatric or other neurological disease
- Having a history of surgery involving the lower extremities, abdominal region or gait
- Known presence of dementia
- Presence of aphasia and apraxia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Spinal stabilization exerciseThe effects of telerehabilitation based spinal stabilization exercise in chronic stroke patients will be investigated. | Other | Face to face Group, Telerehabitation Group |
Primary outcome
Assessment of Physical Activity Level (the mean of the number of steps)
Time frame: 6 weeks
It is planned to measure the physical activity levels of the patients with the Xiaomi Mi Smart Wristband 4.0. It measures the number of steps taken by the users The following information will be saved: The number of steps in one day: .........steps (the mean of steps in seven days)
Assessment of Physical Activity Level (the distance of the patient walks)
Time frame: 6 weeks
It is planned to measure the physical activity levels of the patients with the Xiaomi Mi Smart Wristband 4.0. It measures the distance the patient walk. The following information will be saved: The distance the patients walks in one day:........meters (the mean of the distance in seven days)
Assessment of Physical Activity Level (the time the patient sleeps)
Time frame: 6 weeks
It is planned to measure the physical activity levels of the patients with the Xiaomi Mi Smart Wristband 4.0. It measures the time the patient sleeps. The following information will be saved: The time the patient sleeps in one day:......minutes (the mean of sleep time in seven days)
Assessment of Physical Activity Level (the calories the patient burns)
Time frame: 6 weeks
It is planned to measure the physical activity levels of the patients with the Xiaomi Mi Smart Wristband 4.0. It measures the calories the patients burn. The following information will be saved: he burned calories in one day:..........calories (the mean of the burned calories in seven days)
Fatigue Assessment (physical fatigue)
Time frame: 6 weeks
Fatigue will be assessed with Fatigue Severity Scale (FSS). FSS is a scale with scores ranging from 7 to 63. It includes 9 items. Increase of the score shows severe fatigue.
Fatigue Assessment (cognitive, physical and psychosocial fatigue)
Time frame: 6 weeks
Fatigue will be assessed with Fatigue İmpact Scale (FIS). FIS is a scale with scores ranging from 0 to 160. . It includes 40 items. It has 3 subscales; cognitive fatigue (10 items), physical fatigue (10 items) and psychosocial fatigue (20 items).
Fatigue Assessment (ambulatory fatigue)
Time frame: 6 weeks
Fatigue will be assessed with linear trend of fatigue. Linear trend of fatigue is calculated from the 6 Minute Walk Test. The formula: ([(-5*D1)+(-3*D2)+(-1*D5)+(1*D4)+(3*D5)+(5*D6)])/70 (D1=1 Distance walked in 1st minute, D2=Distance walked in 2nd minute, D3=Distance walked in 3rd minute, D4= Distance walked in 4th minute, D5= Distance walked in 5th minute, D6= distance walked in 6th minute)
4 secondary outcomes
Functional Capacity Assessment
Time frame: 6 weeks
Trunk İmpairment Assessment
Time frame: 6 weeks
Assessment of the Endurance of Core Muscles
Time frame: 6 weeks
Quality of Life Assessment
Time frame: 6 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2024.
- Background: PubMed 19026895Grysiewicz RA, Thomas K, Pandey DK. Epidemiology of ischemic and hemorrhagic stroke: incidence, prevalence, mortality, and risk factors. Neurol Clin. 2008 Nov;26(4):871-95, vii. doi: 10.1016/j.ncl.2008.07.003.
- Background: PubMed 29785009Shepherd AI, Pulsford R, Poltawski L, Forster A, Taylor RS, Spencer A, Hollands L, James M, Allison R, Norris M, Calitri R, Dean SG. Physical activity, sleep, and fatigue in community dwelling Stroke Survivors. Sci Rep. 2018 May 21;8(1):7900. doi: 10.1038/s41598-018-26279-7.
- Background: PubMed 18296944Akuthota V, Ferreiro A, Moore T, Fredericson M. Core stability exercise principles. Curr Sports Med Rep. 2008 Feb;7(1):39-44. doi: 10.1097/01.CSMR.0000308663.13278.69.
- Background: PubMed 23652265Sacco RL, Kasner SE, Broderick JP, Caplan LR, Connors JJ, Culebras A, Elkind MS, George MG, Hamdan AD, Higashida RT, Hoh BL, Janis LS, Kase CS, Kleindorfer DO, Lee JM, Moseley ME, Peterson ED, Turan TN, Valderrama AL, Vinters HV; American Heart Association Stroke Council, Council on Cardiovascular Surgery and Anesthesia; Council on Cardiovascular Radiology and Intervention; Council on Cardiovascular and Stroke Nursing; Council on Epidemiology and Prevention; Council on Peripheral Vascular Disease; Council on Nutrition, Physical Activity and Metabolism. An updated definition of stroke for the 21st century: a statement for healthcare professionals from the American Heart Association/American Stroke Association. Stroke. 2013 Jul;44(7):2064-89. doi: 10.1161/STR.0b013e318296aeca. Epub 2013 May 7.
- Background: PubMed 28154098Boehme AK, Esenwa C, Elkind MS. Stroke Risk Factors, Genetics, and Prevention. Circ Res. 2017 Feb 3;120(3):472-495. doi: 10.1161/CIRCRESAHA.116.308398.
- Background: PubMed 32653056Campbell BCV, Khatri P. Stroke. Lancet. 2020 Jul 11;396(10244):129-142. doi: 10.1016/S0140-6736(20)31179-X.
- Background: PubMed 15370761Geyh S, Cieza A, Schouten J, Dickson H, Frommelt P, Omar Z, Kostanjsek N, Ring H, Stucki G. ICF Core Sets for stroke. J Rehabil Med. 2004 Jul;(44 Suppl):135-41. doi: 10.1080/16501960410016776.
- Background: PubMed 23319483Chen C, Leys D, Esquenazi A. The interaction between neuropsychological and motor deficits in patients after stroke. Neurology. 2013 Jan 15;80(3 Suppl 2):S27-34. doi: 10.1212/WNL.0b013e3182762569.
- Background: PubMed 31195940Paciaroni M, Acciarresi M. Poststroke Fatigue. Stroke. 2019 Jul;50(7):1927-1933. doi: 10.1161/STROKEAHA.119.023552. Epub 2019 Jun 14. No abstract available.
- Background: PubMed 29056502Thilarajah S, Mentiplay BF, Bower KJ, Tan D, Pua YH, Williams G, Koh G, Clark RA. Factors Associated With Post-Stroke Physical Activity: A Systematic Review and Meta-Analysis. Arch Phys Med Rehabil. 2018 Sep;99(9):1876-1889. doi: 10.1016/j.apmr.2017.09.117. Epub 2017 Oct 19.
- Background: PubMed 28157752Belagaje SR. Stroke Rehabilitation. Continuum (Minneap Minn). 2017 Feb;23(1, Cerebrovascular Disease):238-253. doi: 10.1212/CON.0000000000000423.
- Background: PubMed 24139017Key J. 'The core': understanding it, and retraining its dysfunction. J Bodyw Mov Ther. 2013 Oct;17(4):541-59. doi: 10.1016/j.jbmt.2013.03.012. Epub 2013 Jun 28.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Spinal stabilization exercise in people with Stroke, run by Hacettepe University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ali Naim Ceren (+90 554 5662055, alinaimceren@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of Physical Activity Level (the mean of the number of steps) (time frame: 6 weeks). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05306522, which also lists 33 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Mar 2024.